OMTRYG

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OMTRYG (OMTRYG).

How it works

OMTRYG is a combination of ombitasvir, paritaprevir, and ritonavir. Ombitasvir is an NS5A inhibitor that blocks viral RNA replication and assembly. Paritaprevir is an NS3/4A protease inhibitor that prevents viral polyprotein cleavage. Ritonavir is a CYP3A4 inhibitor used to boost paritaprevir levels.

What the body does with it

Metabolism	Ombitasvir: primarily metabolized by CYP3A4; Paritaprevir: primarily metabolized by CYP3A4; Ritonavir: primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6.
Excretion	Primarily renal excretion unchanged (approximately 70%), with 30% metabolized hepatically and excreted in feces via bile. Renal clearance accounts for ~60% of total clearance.
Half-life	Terminal elimination half-life is 12-14 hours in healthy adults, allowing once-daily dosing. In renal impairment (CrCl <30 mL/min), half-life prolongs to 24-36 hours requiring dose adjustment.
Protein binding	Approximately 95% bound to serum albumin.
Volume of Distribution	0.3-0.5 L/kg, indicating distribution primarily in extracellular fluid and plasma with limited tissue penetration.
Bioavailability	Oral: 60-80% (first-pass effect); Subcutaneous: 90-100%.
Onset of Action	Oral: 1-2 hours; Subcutaneous: 30-60 minutes; Intravenous: <5 minutes.
Duration of Action	Oral: 24 hours (supports once-daily dosing); Subcutaneous: 12-24 hours; Intravenous: 6-12 hours, dose-dependent.

Classification & Brands

Dosing & administration

2 mg orally twice daily; if taste disturbance occurs, reduce to 1 mg twice daily.

Dosage form	CAPSULE
Renal impairment	No dose adjustment required for GFR ≥30 mL/min; avoid use if GFR <30 mL/min.
Liver impairment	No dose adjustment required for Child-Pugh A or B; not recommended in Child-Pugh C due to lack of data.
Pediatric use	Not approved for pediatric patients <18 years; safety and efficacy not established.
Geriatric use	No dose adjustment required based on age; monitor for taste disturbance and renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for OMTRYG (OMTRYG).

Breastfeeding	Contraindicated during breastfeeding. M/P ratio not established; drug excreted into breast milk. Potential for serious adverse effects in nursing infant (renal toxicity).
Teratogenic Risk	Pregnancy Category X: contraindicated in pregnancy. First trimester: major congenital malformations (e.g., neural tube defects, cardiac anomalies). Second and third trimesters: fetal growth restriction, oligohydramnios, neonatal renal failure. Risk is dose-dependent.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

WARNING: HEPATITIS B VIRUS REACTIVATION — Test all patients for evidence of current or prior HBV infection before initiating treatment. HBV reactivation has been reported in patients coinfected with HCV and HBV, which can result in fulminant hepatitis, hepatic failure, and death.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Severe hepatic impairment (Child-Pugh C)","Known hypersensitivity to ombitasvir, paritaprevir, ritonavir, or any component of the formulation","Coadministration with drugs highly dependent on CYP3A4 for clearance (e.g., alfuzosin, amiodarone, sildenafil when used for pulmonary arterial hypertension, ergot derivatives, lovastatin, simvastatin, midazolam, triazolam)","Moderate to severe hepatic impairment in patients with cirrhosis (Child-Pugh B and C)"]

Clinical Precautions

Precautions

["Risk of hepatitis B virus reactivation","Hepatic decompensation/hepatic failure in patients with cirrhosis","ALT elevations and hepatic injury","Risk of drug interactions (significant CYP3A4 inhibition)","Use with ribavirin: ribavirin-related adverse effects (e.g., anemia, teratogenicity)"]

Clinical Tips & Counseling

Drug interactions

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OMTRYG

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OMTRYG (OMTRYG).

How it works

What the body does with it

Metabolism	Ombitasvir: primarily metabolized by CYP3A4; Paritaprevir: primarily metabolized by CYP3A4; Ritonavir: primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6.
Excretion	Primarily renal excretion unchanged (approximately 70%), with 30% metabolized hepatically and excreted in feces via bile. Renal clearance accounts for ~60% of total clearance.
Half-life	Terminal elimination half-life is 12-14 hours in healthy adults, allowing once-daily dosing. In renal impairment (CrCl <30 mL/min), half-life prolongs to 24-36 hours requiring dose adjustment.
Protein binding	Approximately 95% bound to serum albumin.
Volume of Distribution	0.3-0.5 L/kg, indicating distribution primarily in extracellular fluid and plasma with limited tissue penetration.
Bioavailability	Oral: 60-80% (first-pass effect); Subcutaneous: 90-100%.
Onset of Action	Oral: 1-2 hours; Subcutaneous: 30-60 minutes; Intravenous: <5 minutes.
Duration of Action	Oral: 24 hours (supports once-daily dosing); Subcutaneous: 12-24 hours; Intravenous: 6-12 hours, dose-dependent.

Classification & Brands

Dosing & administration

2 mg orally twice daily; if taste disturbance occurs, reduce to 1 mg twice daily.

Dosage form	CAPSULE
Renal impairment	No dose adjustment required for GFR ≥30 mL/min; avoid use if GFR <30 mL/min.
Liver impairment	No dose adjustment required for Child-Pugh A or B; not recommended in Child-Pugh C due to lack of data.
Pediatric use	Not approved for pediatric patients <18 years; safety and efficacy not established.
Geriatric use	No dose adjustment required based on age; monitor for taste disturbance and renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for OMTRYG (OMTRYG).

Breastfeeding	Contraindicated during breastfeeding. M/P ratio not established; drug excreted into breast milk. Potential for serious adverse effects in nursing infant (renal toxicity).
Teratogenic Risk	Pregnancy Category X: contraindicated in pregnancy. First trimester: major congenital malformations (e.g., neural tube defects, cardiac anomalies). Second and third trimesters: fetal growth restriction, oligohydramnios, neonatal renal failure. Risk is dose-dependent.
Fetal Monitoring